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A Clinical Evaluation of COVID-19 Rapid Point of Care Antigen Tests

NCT04568356 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2020-10-19

No results posted yet for this study

Summary

The current standard of care for diagnosis of Severe Acute Respiratory Syndrome associated Coronavirus -2 (SARS-CoV-2 ) infection involves sample collection to be prepared and measured via real time-polymerase chain reaction (RT-PCR). This process is often time consuming depending on the level of automation within the laboratory processing the samples. In many cases, sample turn-around times can take hours to several days. A rapid assay that does not require the sophisticated laboratory equipment and techniques could provide a significant advantage to the way practitioners screen and ultimately treat patients. Moreover, the collection of samples from the nasal nares should prove useful and less invasive. The study aims to validate the use of nasal swabs and also to validate the antigen test using nasal swabs.

Conditions

  • SARS CoV-2

Interventions

DIAGNOSTIC_TEST

Direct Antigen Tests for COVID-19

Rapid Antigen diagnostic device performance comparative to RT-PCR

Sponsors & Collaborators

  • SCRI Development Innovations, LLC

    collaborator OTHER

  • E25Bio, Inc.

    lead INDUSTRY

Principal Investigators

  • Gina Remington, RN MSN · HCA Healthcare Director of Research. Neuroscience and Orthopedic

  • Patrice Feaster, RN · SCRI Development Innovations, LLC

  • Klepler N De Almeida, MD · JFK Medical Center

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-24
Primary Completion
2020-06-12
Completion
2020-09-24
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04568356 on ClinicalTrials.gov